Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02636556
Recruitment Status : Active, not recruiting
First Posted : December 21, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kailiang Wu, Fudan University

Brief Summary:
This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Condition or disease Intervention/treatment Phase
Thymoma and Thymic Carcinoma Radiation: concurrent chemoradiation Phase 2

Detailed Description:
Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Intensity modulated radiotherapy with VP-16/Cisplatin
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Actual Study Start Date : June 2011
Actual Primary Completion Date : August 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

Arm Intervention/treatment
Experimental: chemoradiation
concurrent chemoradiation.
Radiation: concurrent chemoradiation
The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 3 months after treatment ]
    Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    from registration to death as a result of any cause.

  2. Progression free survival [ Time Frame: 2 years ]
    from registration to first documentation of disease progression or death.

  3. Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: up to 2 years ]
    Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.18~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.

Exclusion Criteria:

  1. Distant metastases could not be encompassed within a tolerable radiotherapy field;
  2. Underwent surgery, radiotherapy or chemotherapy before entering this study ;
  3. Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;
  4. Active clinical pulmonary infection;
  5. Pregnant or nursing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636556


Locations
Layout table for location information
China, Shanghai
Kailiang Wu
Shanghai, Shanghai, China, 20032
Sponsors and Collaborators
Fudan University
Investigators
Layout table for investigator information
Principal Investigator: Kailiang Wu, M.D.,Ph.D Fudan University

Layout table for additonal information
Responsible Party: Kailiang Wu, professor, Fudan University
ClinicalTrials.gov Identifier: NCT02636556     History of Changes
Other Study ID Numbers: 1508151-5
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kailiang Wu, Fudan University:
thymoma
thymic carcinoma
chemoradiotherapy
inoperable
Additional relevant MeSH terms:
Layout table for MeSH terms
Thymoma
Thymus Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases